A Long-term, Open-label, Uncontrolled Trial of YM443 (Z-338) in Patients With Functional Dyspepsia

Astellas

Status and phase: Completed; Phase 3

Conditions: Functional Dyspepsia; Dyspepsia

Treatments: Drug: YM443

Study type: Interventional

Funder types: Industry

Identifiers

NCT00764374

443-CL-501

Details and patient eligibility

About

To examine the safety and efficacy of Z-338 (YM443) after long-term administration in patients with functional dyspepsia, and also to examine the pattern of long-term administration.

Enrollment: 412 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient showing at least one of the following 4 symptoms from more than 6 months before obtaining consent

  • postprandial fullness
  • early satiation
  • upper abdominal pain
  • upper abdominal discomfort

• Patient showing at least 2 of the 8 symptoms shown below repeatedly from 3 months before obtaining consent (At least one symptom of either postprandial fullness or early satiation should be included.)

• Patient showing either postprandial fullness, bloating in the upper abdomen, or early satiation as the major complaint among the 8 symptoms shown below at the time of obtaining consent

  • upper abdominal pain
  • upper abdominal discomfort
  • postprandial fullness
  • bloating in the upper abdomen
  • early satiation
  • nausea
  • vomiting
  • belching

• Outpatient

Exclusion criteria

• Patient showing symptoms of organic disease (reflux esophagitis, erosion, ulceration, esophageal hiatal hernia, bleeding, malignant tumor, Barrett's esophagus) when upper gastrointestinal endoscopy is performed within 24 weeks before obtaining consent
• Patient showing heartburn within 12 weeks before obtaining consent
• Patient complicated by irritable bowel syndrome
• Patient complicated by diabetes mellitus requiring medication
• Patient complicated by severe anxiety disorder with some problems in interpersonal relationships or social life
• Patient complicated by depression (including suspected cases) or sleep disturbance

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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412 participants in 1 patient group

1

Experimental group

Treatment:

Drug: YM443